Anterior Cruciate Ligament Reconstruction Clinical Trial
Official title:
Implementation of the Knee Care @Home Programme for Patients Recovering Anterior Cruciate Ligament Reconstruction: Protocol for a Randomised Feasibility Trial
The main goal of this trial is to determine the feasibility of a randomized controlled trial for the Knee Care at Home Programme, rather than the effectiveness, for patients recovering from anterior cruciate ligament reconstruction. Specifically, the trial aims to: (1) assess the feasibility of studying the effectiveness of the Knee Care at Home programme, including patient engagement and satisfaction; and (2) conduct a qualitative assessment to identify barriers and facilitators in the implementation and delivery of the programme.
Participants will be asked to take part in a 22-week intervention within a 24-week postoperative rehabilitation period following anterior cruciate ligament reconstruction. Internet-based remote sessions (3 times a week, 40 minutes per session) will supplement conventional clinic-based rehabilitation (face-to-face sessions). After the anterior cruciate ligament reconstruction, outcome measures are assessed during consultations with the orthopedic surgeon. These consultations occur after 4 weeks of intervention interval, except for the second postoperative consultation which occurs after a 2-week intervention period interval. Additional evaluations will occur during each remote session. The team of researchers will evaluate the enrollment (screening, informed consent, eligibility, and allocation), data collection (response rates, missing data, and implementation and technical issues), intervention fidelity (adherence, adherence rate at remote sessions, adherence at conventional rehabilitation, quality of delivery, participant responsiveness, and safety), and acceptability (patient satisfaction and motivation). ;
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